Events

Retiro De Equipo (Recall) de Fluid Management System P4000

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Thermedx LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    69996
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1463-2015
  • Fecha de inicio del evento
    2014-09-01
  • Fecha de publicación del evento
    2015-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132087
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Insufflator, hysteroscopic - Product Code HIG
  • Causa
    To correct software bugs that could affect the ability to accurately measure fluid deficit.
  • Acción
    Thermedx sent an Urgent Product Correction letter dated March 13. 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm informed their customers that the software update will be performed at customer locations by Thermedx trained and authorized personnel. A Thermedx and/or your Sales Representative will contact customers to schedule a time to perform the field service update. Should you have any questions regarding this notification, please call a Thermedx technical service representative. Support is available toll free at 1-888-542-9276 from 8AM to 5PM Monday to Friday Eastern Standard Time or by e-mailing techservice@thermedx.com. Our website may be found at www.thermedx.com. We sincerely apologize for the inconvenience and thank you in advance for your cooperation.

Device

Fluid Management System P4000
  • Modelo / Serial
    Serial Numbers 20100001 through 20140044
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
  • Descripción del producto
    Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
  • Manufacturer
    Thermedx LLC

Manufacturer

Thermedx LLC
  • Dirección del fabricante
    Thermedx LLC, 31200 Solon Rd, Unit 1, Solon OH 44139-3556
  • Empresa matriz del fabricante (2017)
    Thermedx LLC
  • Source
    USFDA